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Roche Requests Re-Examination of CHMP Opinion on Tarceva in Pancreatic Cancer at the European Medicines Agency

Basel, Switzerland (ots/PRNewswire)

- First Treatment for Years to Have Shown a Significant Survival
Benefit for Patients
Roche announced today that it has requested a re-examination of
the data supporting the filing of their breakthrough cancer medicine,
Tarceva, for the treatment of pancreatic cancer following the recent
negative opinion from the European Committee for Medicinal Products
for Human Use (CHMP).
The filing was specifically for the use of Tarceva (erlotinib) in
combination with gemcitabine chemotherapy for the first line
treatment of advanced pancreatic cancer. Pancreatic cancer is one of
the most aggressive forms of cancer killing more people within the
first year of diagnosis than any other cancer. (1) People with
pancreatic cancer have limited treatment options and Tarceva is the
first treatment for many years to have shown a significant survival
benefit in patients with pancreatic cancer.
"People with pancreatic cancer need new treatment options like
Tarceva which has been proven in clinical trials to significantly
increase survival and has already been approved for this indication
in the US," said Eduard Holdener, Head of Global Drug Development.
"In light of this, we are asking the CHMP to re-consider its
opinion."
Tarceva was granted a licence by the American FDA (Food and Drug
Administration) in November 2005 for the first-line treatment of
patients with locally advanced, unresectable or metastatic pancreatic
cancer in combination with gemcitabine chemotherapy. Both the US and
the EU license applications are based on data from the Phase III
study (PA3)(2) which showed that treatment with Tarceva plus
gemcitabine results in significantly longer survival (22%) compared
to gemcitabine alone. 24% of patients receiving Tarceva plus
gemcitabine were alive after one year, compared to 19% on gemcitabine
alone.
Roche and its partners are committed to realising the potential of
Tarceva in treating pancreatic cancer through its extensive clinical
trial programme, including a Roche-sponsored randomised, double
blind, placebo controlled study of gemcitabine and Tarceva +/-
Avastin in patients with metastatic pancreatic cancer (AVITA or
BO17706). Tarceva is approved and marketed in the US and across the
European Union for patients with locally advanced or metastatic
non-small cell lung cancer (NSCLC) after failure of at least one
prior chemotherapy regimen.
A variation application was submitted to the European Health
Authorities in October 2005 for Tarceva plus gemcitabine chemotherapy
for the first-line treatment of patients with advanced pancreatic
cancer. In April 2006, Chugai Pharmaceutical Co., Ltd. filed a New
Drug Application (NDA) with the Japanese Ministry of Health, Labour
and Welfare (MHLW) for Tarceva in patients with advanced or recurrent
NSCLC.
About the PA3 study(2)
The pivotal Phase III randomised study (PA3)(2) of 569 patients
was conducted by the National Cancer Institute of Canada Clinical
Trials Group based at Queen's University. The double blind study
evaluated Tarceva's efficacy in patients with locally advanced or
metastatic pancreatic cancer.
The results of PA3(2) demonstrated the following:
  • Treatment with Tarceva plus gemcitabine in patients with advanced pancreatic cancer resulted in significantly longer survival compared to gemcitabine alone (22%)
  • 24% of patients receiving Tarceva plus gemcitabine were alive after one year, compared to 19% on gemcitabine alone
  • Patients receiving Tarceva plus gemcitabine experienced significantly longer progression-free survival of 30%
  • Tarceva plus gemcitabine was well tolerated by patients with no increase in haematological toxicity; expected rash and diarrhoea were the principal Tarceva-related side effects seen in the study and were generally characterised as mild-to-moderate
  • Tarceva plus gemcitabine reported a safety profile generally consistent with that seen in other studies both monotherapy and combination settings
About pancreatic cancer
Pancreatic cancer is the tenth most frequently occurring cancer in
Europe.(3) The main risk factors for pancreatic cancer include
advanced age, cigarette smoking, a high-fat diet, diabetes mellitus,
chronic inflammation of the pancreas (pancreatitis), especially
hereditary pancreatitis, and a family history of pancreatic
cancer.(4) The symptoms vary depending upon where the tumour is in
the pancreas. The major symptoms are weight loss, abdominal pain and
jaundice. (1) The disease is rapidly fatal and attempts to improve
survival over the past 10 years have been unsuccessful.
About Tarceva
Tarceva (erlotinib) is a small molecule that targets the human
epidermal growth factor receptor (HER1) pathway. HER1, also known as
EGFR, is a key component of this signalling pathway, which plays a
role in the formation and growth of numerous cancers. Tarceva blocks
tumour cell growth by inhibiting the tyrosine kinase activity of the
HER1 signalling pathway inside the cell.
Taken as an oral, once-daily therapy, Tarceva is the only
EGFR-inhibitor to have demonstrated a survival benefit in lung cancer
- a striking 42.5%. Currently most lung cancer patients are treated
with chemotherapy which can be very debilitating due to its toxic
nature. Tarceva works differently to chemotherapy by specifically
targeting tumour cells, and avoids the typical side-effects of
chemotherapy.
Tarceva is approved in the US and across the EU for patients with
locally advanced or metastatic non-small cell lung cancer (NSCLC)
after failure of at least one prior chemotherapy regimen.
Tarceva has been approved by the FDA since November 2, 2005 for
the first-line treatment of locally advanced, unresectable or
metastatic pancreatic cancer in combination with gemcitabine
chemotherapy.
Tarceva is currently being evaluated in an extensive clinical
development programme by a global alliance among OSI Pharmaceuticals,
Genentech and Roche, focussing on earlier stages of NSCLC.
Additionally, Tarceva is being studied in combination with Avastin in
NSCLC. Trials are also being conducted with Tarceva in other solid
tumours, such as ovarian, bronchioloalveolar (BAC), colorectal,
pancreatic, head and neck and glioma (brain).
About Roche
Headquartered in Basel, Switzerland, Roche is one of the world's
leading research-focused healthcare groups in the fields of
pharmaceuticals and diagnostics. As a supplier of innovative products
and services for the early detection, prevention, diagnosis and
treatment of disease, the Group contributes on a broad range of
fronts to improving people's health and quality of life. Roche is a
world leader in diagnostics, the leading supplier of medicines for
cancer and transplantation and a market leader in virology. In 2005
sales by the Pharmaceuticals Division totalled 27.3 billion Swiss
francs, and the Diagnostics Division posted sales of 8.2 billion
Swiss francs. Roche employs roughly 70,000 people in 150 countries
and has R&D agreements and strategic alliances with numerous
partners, including majority ownership interests in Genentech and
Chugai. Additional information about the Roche Group is available on
the Internet (www.roche.com).
All trademarks used or mentioned in this release are protected by
law.
For further information about:
References:
1. Steward, B W and Kleihues, P. 2003. World Cancer Report. World
Health Organisation and the International Agency for Research on
Cancer, IARC Press/Lyon, p248
2. Moore MJ, Goldstein D, Hamm J, et al. Erlotinib plus
gemcitabine compared to gemcitabine alone in patients with advanced
pancreatic cancer. A Phase III trial of the National Cancer Institute
of Canada Clinical Trials Group [NCIC-CTG]. (Abstract #1, ASCO 2005)
3. De Braud F, Cascinu S, Gatta G. 2004, May. Cancer of Pancreas.
Critical reviews in oncology/hematology, 50(2):147-55
4. Truninger K (ed). 2002, Aug. Risk groups for pancreatic and
bile duct carcinomas. Schweizerische Rundschau fur Medizin Praxis,
17;89 (33):1299-304

Contact:

Media Contacts: Roche Group Media Office, Phone: +41-61-688-8888,
e-mail: basel.mediaoffice@roche.com - Baschi Durr, - Alexander
Klauser, - Daniel Piller (Head of Roche Group Media Office), - Katja
Prowald (Head of R&D Communications), - Martina Rupp

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